Sleep Well Live Well (SWELL) Pilot Project

NCT04849572 | Completed

• 1 other identifier: 2103262999
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a 12 week randomized control trial of sleep hygiene education vs. no education with a cross-over to the active intervention after 6 weeks. Primary and secondary outcomes will be assessed before and after a 10-20 minute sleep hygiene video (intervention).

Conditions

Sleep Hygiene

Outcome Measures

Primary Outcomes (3)

• Difference in total sleep time

  A 20 minute or more difference in total sleep time between Arm 1 (sleep education) and Arm 2 (no initial sleep education).

  6 Weeks

• Change in the ESS in Arm 1 (≥2 points)

  The Epworth Sleepiness Scale (ESS) is widely used in the field of sleep medicine as a subjective measure of a patient's sleepiness. The test is a list of eight situations in which the subjects rate their tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. When the subjects finish the test, add up the values of the responses. The subjects total score is based on a scale of 0 to 24. The scale estimates whether the subjects are experiencing excessive sleepiness that possibly requires medical attention.

  6 Weeks

• Change in PSQI at 6 weeks in Arm 1 (≥3 points)

  The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Only self-rated questions are included in the scoring. The 19 self-rated items are combined to form seven "component" scores, each of which has a range of 0-3 points. In all cases, a score of "O" indicates no difficulty, while a score of "3" indicates severe difficulty. The seven component scores are then added to yield one "global" score, with a range of 0-21 points, "O" indicating no difficulty and "21 " indicating severe difficulties in all areas.

  6 Weeks

Secondary Outcomes (3)

• Change in total sleep time

  6 weeks after sleep education

• Change in daytime alertness as measured by psychomotor vigilance testing (PVT) in both groups

  6 weeks after sleep education

• Change in heart rate variability in both groups

  6 weeks after sleep education

Study Arms (2)

Sleep Education

ACTIVE COMPARATOR

Also referred to as Arm 1. Arm 1 receives sleep education initially.

Behavioral: Sleep Education

Delayed Sleep Education

ACTIVE COMPARATOR

Also referred to Arm 2. Arm 2 receives no initial sleep education.

Behavioral: Delayed Sleep Education

Interventions

Sleep Education BEHAVIORAL

* Week 1-2: All 100 participants will have sleep parameters recorded as baseline for the first two weeks. * Week 3: 50 participants (Arm 1) will watch a 10 to 20 minute sleep hygiene video followed by a post-test questionnaire to confirm participation and understanding. * Week 5: Arm 1 will again view the educational video at week 5 * Week 6-8: Baseline sleep data on all participants will be downloaded for review and the PSQI questionnaire administered for both groups. Participants will be also be asked if they underwent any major health crisis during the study period which may have impacted their sleep (hospitalization, significant medication changes which they believe impacted sleep, any use of illicit drugs during the study periods or significant increase in alcohol consumption (e.g., doubling). * Week 9: Arm 1 will continue re-education * Week 11: Arm 1 continues education * Week 12-14: Data from Oura ring will be downloaded and PSQI administered to both groups.

Sleep Education

Delayed Sleep Education BEHAVIORAL

* Week 1-2: All 100 participants will have sleep parameters recorded as baseline for the first two weeks. * Week 3: 50 participants (Arm 2) will be controls with no education. * Week 6-8: Baseline sleep data on all participants will be downloaded for review and the PSQI questionnaire administered for both groups. Participants will be also be asked if they underwent any major health crisis during the study period which may have impacted their sleep (hospitalization, significant medication changes which they believe impacted sleep, any use of illicit drugs during the study periods or significant increase in alcohol consumption (e.g., doubling). * Week 9: Arm 2 will join in for video education along with post-test * Week 11: Arm 2 will undergo reeducation with post-test for 20 mins * Week 12-14: Data from Oura ring will be downloaded and PSQI administered to both groups.

Delayed Sleep Education

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Efforts will be made to have 50% female participation to reflect the gender ratio in Appalachia. A total of 100 subjects (50 per group) will be randomized to each treatment group, stratified by gender.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Reside in Harrison County of West Virginia
• Ability to read and understand English
• Ability to provide informed consent

You may not qualify if:

• Inability to read and understand English
• Inability or unwillingness to provide informed consent
• Presence of sleep apnea
• Depression
• Severe insomnia
• Using prescription sleeping medication or narcotics
• Acute illness including stroke, heart attack, heart failure or pneumonia with or without COVID-19 infection requiring hospital admission within the last 8 weeks

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26508, United States

Location

Related Publications (1)

• Sharma S, Stansbury R, Ramadan J, Rojas E, Finomore V, Pham C, Quan SF, Wen S. Sleep well and live well: Impact of sleep hygiene intervention on sleep duration in a rural community: A randomized controlled trial (THE SWELL STUDY). J Rural Health. 2025 Jan;41(1):e70002. doi: 10.1111/jrh.70002.

  PMID: 39930329 DERIVED

MeSH Terms

Conditions

Sleep Hygiene

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a permuted block randomization study to assess the efficacy of the new intervention and the primary outcome variable is the sleep time. A total of 100 subjects (50 per group) will be randomized to each treatment group, stratified by gender. The first group will receive the intervention and be enrolled into the trial after the run-in period and the baseline data collection, and the second group will receive the intervention at 6 weeks after trial start.

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 19, 2021
• Study Start: September 14, 2021
• Primary Completion: May 6, 2022
• Study Completion: May 6, 2022
• Last Updated: February 24, 2025

Record last verified: 2023-08

Locations

US (1)